Placebo | Tralokinumab | ||||
Combined tralokinumab | 150 mg | 300 mg | 600 mg | ||
Subjects n | 48 | 146 | 47 | 51 | 48 |
Age yrs | 47.2±9.8 | 47.4±11.1 | 43.4±11.1 | 48.7±11.0 | 49.8±10.4 |
Male | 15 (31.3) | 63 (43.2) | 28 (59.6) | 15 (29.4) | 20 (41.7) |
White | 42 (87.5) | 136 (93.2) | 46 (97.9) | 46 (90.2) | 44 (91.7) |
BMI kg·m−2 | 27.0 (18.9–34.8) | 27.1 (18.5–35.3) | 26.6 (18.9–35.3) | 27.5 (18.5–34.9) | 27.2 (19.2–34.6) |
FEV1 L | 1.94±0.48+ | 2.01±0.65 | 2.20±0.67 | 1.90±0.59 | 1.96±0.66 |
FEV1 % pred | 61.4±12.3+ | 61.2±12.3 | 61.9±12.7 | 61.1±12.6 | 60.5±11.8 |
FEV1 reversibility %# | 27.0±17.9 | 30.2±16.7 | 28.3±17.7 | 33.4±18.3 | 29.3±14.4 |
FVC L | 3.25±0.80+ | 3.26±1.02 | 3.56±0.95 | 3.08±1.01 | 3.15±1.04 |
PEF L | 284.9±79.6+ | 313.2±112.3 | 341.2±118.6 | 290.5±97.0 | 309.9±117.5 |
Median ICS dose¶ μg·day−1 | 1000 | 1000 | 1000 | 1000 | 1000 |
Subjects receiving daily OCS | 0 (0) | 9 (6.2) | 3 (6.4) | 3 (5.9) | 3 (6.3) |
Rescue β2-agonist use puffs·day−1 | 2.60±1.68+ | 2.47±1.85 | 2.80±2.03 | 2.04±1.51 | 2.60±1.95 |
ACQ-6 score | 2.60±0.54+ | 2.68±0.63 | 2.68±0.62 | 2.63±0.50 | 2.72±0.75 |
Overall AQLQ(S) score | 4.15±0.83§ | 4.07±0.87ƒ | 3.90±0.88## | 4.15±0.80## | 4.16±0.94§ |
Data are presented as mean±sd, n (%) or mean (range), unless otherwise stated. BMI: body mass index; FEV1: forced expiratory volume in 1 s; % pred: % predicted; FVC: forced vital capacity; PEF: peak expiratory flow; ICS: inhaled corticosteroids; OCS: oral corticosteroids; ACQ-6: Asthma Control Questionnaire, mean of six individual item scores; AQLQ(S): Asthma Quality of Life Questionnaire with standardised activities. #: mean reversibility of subjects who demonstrated reversibility during screening (excluding those who reported historical reversibility); ¶: beclometasone equivalent; +: n=47; §: n=36; ƒ: n=114; ##: n=39.